Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis

Part of paid clinical trials in Orange, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06704269
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • YTB323 — GENETIC
    CAR-T cell suspension for intravenous infusion

Study Details

This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.

Key Dates

Start date
Apr 22, 2025
Status verified
Apr 2026
Primary completion
Oct 26, 2029
Completion
Oct 26, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: YTB323
    YTB323 single intravenous (i.v.) infusion

Primary Outcome Measure

Occurrence, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 2 years ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (3)

FacilityCityStateZIPSite coordinators
Univ Cali Irvine ALS NeuromuscularOrangeCalifornia92868
UCI Alpha Clinic
[email protected]
949-824-3990
Ali Habib (PRINCIPAL_INVESTIGATOR)
Wake Forest Univ School of MedicineWinston-SalemNorth Carolina27157-1052
Katie Hoots
[email protected]
336-716-1049
Rachana Gandhi Mehta (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Jennifer Garrett
[email protected]
346-238-4516
Ericka Greene (PRINCIPAL_INVESTIGATOR)

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By research site
Univ Cali Irvine ALS Neuromuscular· Orange, CAWake Forest Univ School of Medicine· Winston-Salem, NCHouston Methodist Hospital· Houston, TX

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